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In order to explore the effect of acupuncture on the clinical outcome of IVF-ET in patients with recurrent implantation failure, the patients divide into the experimental group or the control group. In the experimental group, those patients undergo acupuncture at the beginning of embryo transfer cycle three times a week until 14 days after embryo transfer. In the control group, those patients do not receive any treatments during embryo transfer cycle. Statistical analysis of the two groups of primary endpoint and secondary endpoint are done.
In the field of assisted reproduction techonology, there are still 10% of patients with recurrent implantation failure. In order to explore the effect of acupuncture on the clinical outcome of IVF-ET in patients with recurrent implantation failure, the patients divide into the experimental group or the control group. In the experimental group, those patients undergo acupuncture at the beginning of embryo transfer cycle three times a week until 14 days after embryo transfer. In the control group, those patients do not receive any treatments during embryo transfer cycle. Both of two group patients are checked including endometrial receptivity index and fill in SAS anxiety scale form. Statistical analysis of the two groups of primary endpoint (clinical pregnancy rate) and secondary endpoint (embryo implantation rate, biochemical pregnancy rate, early pregnancy loss rate, ongoing pregnancy rate, live birth rate)are done.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acupuncture group | Experimental | In the acupuncture group, those patients undergo acupuncture at the beginning of embryo transfer cycle three times a week until 14 days after embryo transfer. These patients should be checked including endometrial receptivity index and fill in SAS anxiety scale form. |
|
| Control group | No Intervention | In the control group, these patients do not receive any treatments during embryo transfer cycle. These patients should be checked including endometrial receptivity index and fill in SAS anxiety scale form. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| acupuncture | Procedure | Patients undergo acupuncture at the beginning of embryo transfer cycle three times a week until 14 days after embryo transfer. Every acupuncture lasts 20 minutes. |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical pregnancy rate | Clinical pregnancy will be defined as ultrasonographic evidence of an intrauterine sac with or without a fetal heart at the 6th gestational week. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| embryo implantation rate | The embryo implantation rate (IR) will be calculated as the number of gestational sacs per embryo transferred | 6 months |
| biochemical pregnancy rate | Biochemical pregnancy will be defined by a serum HCG level ≥5.0 mIU/ml approximately 14 days after embryo transfer |
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Inclusion Criteria:
1. A: ≥ 3 times embryo transfer failures,and at least accumulated 4 high-quality embryos were transferred
B: Two times consecutive embryo transfers failures, at least accumulated 4 high-quality embryos were transferred
2. Undergo IVF / ICSI / PGT;
3. Transfer 1-2 D3 cleavage embryos or blastocysts in IVF / ICSI and transfer 1 blastocyst in PGT;
4. 20-38 years old female
5. Sign the informed consent voluntarily.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wenbi Zhang, Doctor | Contact | +8602163459977 | jackeyzhang0905@163.com | |
| He Li, Doctor | Contact | +8602163459977 | lihe198900@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Xiaoxi Sun | Obstetrics and Gynecology Hospital affiliated to Fudan University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Ji Ai Genetics & IVF Institute, Obstetrics and Gynecology Hospital of Fudan University | Recruiting | Shanghai | Shanghai Municipality | 200011 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16600232 | Background | Westergaard LG, Mao Q, Krogslund M, Sandrini S, Lenz S, Grinsted J. Acupuncture on the day of embryo transfer significantly improves the reproductive outcome in infertile women: a prospective, randomized trial. Fertil Steril. 2006 May;85(5):1341-6. doi: 10.1016/j.fertnstert.2005.08.070. Epub 2006 Apr 5. | |
| 11937123 | Background |
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| ID | Term |
|---|---|
| D015670 | Acupuncture Therapy |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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| 6 months |
| early pregnancy loss rate | Early pregnancy loss will be considered pregnancy loss occurring after detection of a clinical pregnancy up to the 12th week of pregnancy | 6 months |
| ongoing pregnancy rate | OPR was calculated by considering all viable intrauterine pregnancy progressing beyond 12 weeks of gestation. | 6 months |
| live birth rate | Live birth rates were calculated based on the total number of live births > 20 weeks' gestation over the total number of ongoing pregnancies. | 12 mongths |
| Paulus WE, Zhang M, Strehler E, El-Danasouri I, Sterzik K. Influence of acupuncture on the pregnancy rate in patients who undergo assisted reproduction therapy. Fertil Steril. 2002 Apr;77(4):721-4. doi: 10.1016/s0015-0282(01)03273-3. |
| 16616748 | Background | Dieterle S, Ying G, Hatzmann W, Neuer A. Effect of acupuncture on the outcome of in vitro fertilization and intracytoplasmic sperm injection: a randomized, prospective, controlled clinical study. Fertil Steril. 2006 May;85(5):1347-51. doi: 10.1016/j.fertnstert.2005.09.062. Epub 2006 Apr 17. |